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A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage III Colon Cancer

Eligibility Criteria
Histologically documented adenocarcinoma of the colon. The gross inferior (caudad) margin of the primary tumor must lie above the peritoneal reflection (i.e., patients with rectal cancer are not eligible). Surgeon confirmation that the entire tumor was above the peritoneal reflection is only required in cases where it is important to establish if the tumor is a rectal or colon primary.

Tumors must have been completely resected. In patients with tumor adherent to adjacent structures, en bloc Ro resection must be documented in the operative report. Near or positive radial margin are not exclusions as long as en bloc resection was performed. Positive proximal margin or distal margin is an exclusion.

Treatment must begin no less than 21 days and no more than 56 days after definitive surgical resection of the primary tumor.

Node positive disease (N1 or N2) as designated in AJCC version 7. Either at least one pathologically confirmed positive lymph node or N1C (defined as tumor deposit(s) in the subserosa, mesentery, or nonperitonealized pericolic or perirectal tissues without regional lymph node metastases).

No evidence of residual involved lymph node disease or metastatic disease at the time of registration.

Patients with synchronous colon cancers are eligible and staging for stratification will be based on higher N stage of the more advanced primary tumor. However, patients with synchronous colon and rectal primary tumors are not eligible.

Patients are ineligible if they plan on regular use of NSAIDs at any dose more than 2 times per week (on average) or aspirin at more than 325 mg at least three times per week, on average. Low-dose aspirin not exceeding 100 mg/day is permitted. Patients who agree to stop regular NSAIDs or higher dose aspirin are eligible and no wash out period is required.

No previous or concurrent malignancy, except treated basal cell or squamous cell cancer of skin, treated in situ cervical cancer, treated lobular or ductal carcinoma in situ in one breast, or any other cancer for which the patient has been disease-free for at least 5 years.

No neurosensory or neuromotor toxicity ≥ grade 2 at the time of registration.

No known allergy to platinum compounds.

No prior allergic reaction or hypersensitivity to sulfonamides, celecoxib or NSAIDs.

No history of upper gastrointestinal ulceration, upper gastrointestinal bleeding, or upper gastrointestinal perforation within the past 3 years. Patients with ulceration, bleeding or perforation in the lower bowel are not excluded.

No symptomatic pulmonary fibrosis or interstitial pneumonitis ≥ grade 2.

No cardiac risk factors including:

  • Uncontrolled high blood pressure (systolic blood pressure > 150 mm Hg)
  • Unstable angina
  • History of documented myocardial infarction or cerebrovascular accident
  • New York Heart Association Class III or IV heart failure

Non-pregnant and not nursing. Men and women of childbearing potential must agree to employ adequate contraception for the duration of chemotherapy and for as many as 8 weeks after the completion of chemotherapy due to the unknown teratogenic effects of FOLFOX on the developing fetus.

ECOG performance status 0, 1, or 2.

Age at least 18 years.

Required initial laboratory values:

  • Granulocytes ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Creatinine ≤ 1.5 x upper limit of normal
  • Bilirubin ≤ 1.

5 x upper limit of normal

Treatment Plan
Eligible patients are randomized to one of four arms:

Arm A:  FOLFOX 12 cycles + Placebo daily for 3 years
Arm B:  FOLFOX 12 cycles + Celecoxib 400 mg daily for 3 years
Arm C:  FOLFOX 6 cycles + Placebo daily for 3 years
Arm D:  FOLFOX 6 cycles + Celecoxib 400 mg daily for 3 years

Celecoxib / Placebo is provided free of charge for study participants